CURITY POVIDONE-IODINE ONE-STEP PREP- povidone-iodine gel 
Aplicare Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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4193 Curity Povidone-Iodine One-Step Prep

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

  • For external use only.
  • Avoid "pooling beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Do not use

  • • if allergic to iodine
  • • in the eyes

Ask a doctor before use if injuries are

  • • deep or puncture wounds
  • • serious burns

Stop use and ask a doctor if

  • • infection occurs
  • • redness, irritation, swelling or pain persists or increases

Keep out of reach of children.

  • In case of accidental ingestion, seek professional assistance or consult a Poison Control Center immediately.

Directions

  • • apply locally as needed

Other information

  • • 1% titratable iodine
  • • for hospital or professional use only
  • • avoid freezing and excessive heat (above 104°F)
  • • not made with natural rubber latex

Inactive ingredients

disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water

Manufacturing Information

Manufactured for:

Covidien LLC

15 Hampshire Street, Mansfield MA 02048 USA

HP105792

REF: APL41461

Package Label

Povidone-Iodine Gel

CURITY POVIDONE-IODINE ONE-STEP PREP 
povidone-iodine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-4193
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE9.7 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL HYDROXYETHYLCELLULOSE (550000 MW) (UNII: 2MIM45ZIL3)  
NONOXYNOL-10 (UNII: K7O76887AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-4193-8109 mL in 1 BOTTLE; Type 0: Not a Combination Product02/14/201807/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/199807/01/2022
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2021
Document Id: d27de79c-4700-50a7-e053-2995a90a208f
Set id: 3551982f-ad6c-435f-b880-c318bf04b565
Version: 4
Effective Time: 20211206
 
Aplicare Products, LLC